(44 days)
The device is intended to treat benign superficial dermatological indications that includes; warts, molluscum contagiosm, angioma, fibroma, seborrheic keratoses, acrochordon, syringoma, hydrocystoma, calvus, actinic keratoses, keloids, epidermoid cysts, cystic acne, cutaneous leishmaniasis, atypical mycobacteria, and dermatophytosis. In addition, it is intended to treat basal cell carcinoma.
The ThermoMed Model 1.8 is a battery-operated device that delivers precisely controlled localized current field radio frequency heat to selectively destroy certain diseased tissue.
Here's an analysis of the provided text regarding the ThermoMed Model 1.8 device, focusing on acceptance criteria and the study proving its performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Low occurrence of adverse events. | Treatment related side effects were low: two reports of mild infection at the treatment site, one report of pain after treatment, and one report of lightheadedness. |
| Efficacy (Basal Cell Carcinoma): A significant percentage of patients show no evidence of tumor cells. | Eighty-five (85) percent of patients showed no evidence of tumor cells upon histological examination 3 months after a single treatment. |
| Patient Satisfaction (Comfort): High patient rating for comfort. | Average patient rating for treatment comfort was 8.35 (on a 1-10 scale with 10 being most favorable). |
| Patient Satisfaction (Convenience): High patient rating for convenience. | Average patient rating for treatment convenience was 8.97 (on a 1-10 scale with 10 being most favorable). |
| Patient Satisfaction (Side Effects): High patient rating regarding side effects. | Average patient rating for side effects was 9.02 (on a 1-10 scale with 10 being most favorable). |
Note: The document does not explicitly state "acceptance criteria" with numerical thresholds. The "reported device performance" are the results presented from the clinical trial, which implicitly serve as demonstration of acceptable performance for the device's intended use, particularly for basal cell carcinoma. The study concludes that the data "shows safety and effectiveness of the device."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 60 patients.
- Data Provenance: The study was a "single center study." The document does not specify the country of origin, but given the 510(k) submission to the FDA (United States), it is highly probable the study was conducted in the USA.
- Retrospective or Prospective: The phrasing "A single center study... was conducted to evaluate the safety and efficacy" indicates a prospective study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document states that efficacy was determined by "histological examination 3 months after a single treatment." This implies that a pathologist or a team of pathologists established the ground truth for the presence or absence of tumor cells. However, the document does not specify the number of experts used or their specific qualifications (e.g., years of experience).
4. Adjudication Method for the Test Set
The document does not provide details about an adjudication method (such as 2+1 or 3+1 consensus) for establishing the ground truth from histological examinations. It's common practice for pathological assessments to be performed by a single pathologist, or for challenging cases to be reviewed by multiple pathologists for consensus, but this specific detail is not mentioned in the provided text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The described study evaluates the device's performance in treating basal cell carcinoma directly, not by comparing human reader performance with and without AI assistance. The ThermoMed Model 1.8 is a therapeutic device, not a diagnostic AI system for image interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
N/A. This question is not applicable. The ThermoMed Model 1.8 is a physical medical device (localized current field radio frequency instrument) that is applied by a healthcare professional to treat conditions. It is not an algorithm or an AI system that operates in a "standalone" or "human-in-the-loop" fashion for diagnostic interpretation.
7. The Type of Ground Truth Used
The primary ground truth for efficacy in the basal cell carcinoma study was histology (pathology), specifically "no evidence of tumor cells upon histological examination." Patient satisfaction data was self-reported by patients.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" because the study described is a clinical trial to evaluate the safety and efficacy of a therapeutic device, not to train or validate a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no mention of a training set for an AI/ML algorithm. The clinical trial described focuses on the direct physiological effect of the device on patients.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.